Evrysdi 0.75 mg/mL powder for oral solution (risdiplam): Omission of mandatory labelling statement in the EU product label and summary of product characteristics
26/08/2025
Medicines for human use
Direct healthcare professional communication (DHPC)
Important Safety Information from Roche Products (Ireland) Limited regarding Evrysdi 0.75 mg/mL powder for oral solution (risdiplam) dated 21 August 2025: Omission of mandatory labelling statement in the EU product label and summary of product characteristics